accelerating time to market with the power of cloud...

AccelerAting time to mArket with the Power of cloud-BAsed integrAtion

www.liaisonhealthcare.com

Now more than ever before,

flat revenue and increased

development costs have made

time-to-market a crucial

factor in profitability for the

pharmaceutical and biotech

industries. Fortunately, new

protocols and technologies

are growing at a rapid pace,

making this a time of change

and opportunity in the life

sciences industry.

A white PAPer for PhArmAceuticAl And Biotech industries Now more than ever before, flat revenue and increased development costs have made time-to-market

a crucial factor in profitability for the pharmaceutical and biotech industries. Just as companies are

starting to look for ways to speed product launches, however, increased regulation has made it

more difficult to get drugs and devices through the review process. Fortunately, new protocols and

technologies are also growing at a rapid pace, making this a time of both change and opportunity in the

life sciences industry.

Thanks to initiatives such as the Biomedical Research Integrated Domain Group (BRIDG), companies

today have more access to data than in the past. Other recent advances in patient recruitment and

clinical trial management such as globalization and adaptive trials are giving the industry new solutions

to improve speed to market. Yet at the same time, mergers, acquisitions and outsourcing are improving

operational efficiencies but creating new obstacles because of decentralized data.

The challenge with all of these new opportunities lies in how quickly and efficiently companies can

analyze clinical data from different sources to make key business decisions. With disparate information

housed in silos, time to market can be slowed by inaccurate data or scalability issues, as well as time-

intensive manual data entry and rework.

All of these trends require a new thought process around building data management platforms that can

quickly integrate, aggregate and harmonize information. Legacy systems do not have these advanced

capabilities and developing new systems internally typically requires extensive investment in technology

and resources. Internal IT staff can seldom keep up with the demands of new compliance and business

requirements while also facing pressures to develop leading-edge data infrastructures.

outmoded Processes cAn’t keeP PAce with PhArmAceuticAl innovAtionWhile current data management techniques have made progress, they face significant challenges

when it comes to true integration and collaboration. These challenges will become even more apparent

as trends and innovations within the industry continue to shape the way pharmaceutical and biotech

companies do business.

For example, traditional point-to-point and ad hoc integration can lead to problems with data integrity

and require manual steps to share data. Applications often involved include Electronic Data Capture

(EDC), Clinical Data Management Systems (CDMS), Clinical Trial Management Systems (CTMS),

Clinical Data Repositories (CDR) and Statistical Analysis System (SAS) Analytics.


In addition, many platforms have difficulty with collaboration. Three common approaches—traditional

integration, extended integration and external integration—each offer distinct advantages and

disadvantages based on their application and use:

• Traditional integration typically is used with internally managed trials only, since collaboration with

outside entities is limited.

• Extended integration via the web or through a virtual private network (VPN) allows for some

external sharing of data through the employment of security measures that extend applications

to partners. However, lab data is still an external integration issue, and scalability can be difficult

with this approach. Internal hosting costs can be high, and this is not a core competency for most

internal IT resources.

• External integration allows companies to receive incremental or final data sets from CROs, labs

and other entities, but it is essentially a custom mapping and migration exercise. Scalability of

applications, especially involving global business units, can be difficult and hosting costs with this

method also can be high.

cloud-BAsed dAtA mAnAgement suPPorts the future of life sciencesAs the industry continues to struggle with the limitations of traditional data management approaches,

advances in cloud-based technology have presented a unique solution for the future. Other industries

such as financial services, consumer packaged goods and retail have capitalized on cloud-based

infrastructure to support the management of vast amounts of data for global operations and

communications. These best practices have allowed for the development of systems that support

sophisticated data integration through a Platform as a Service (PaaS) model.

To understand data integration through a Platform as a Service model, you must first examine the

different aspects or layers of the cloud itself. Cloud technology is perhaps best known for supporting

Infrastructure as a Service (IaaS), where companies pay for space and usage of hardware, CPU space,

memory and firewalls. This is truly the “bottom layer” of the cloud, which allows companies to expand

and reduce their need for infrastructure with ease.

As the industry continues to

struggle with the limitations of

traditional data management

approaches, advances in

cloud-based technology have

presented a unique solution

for the future.

Sophisticated data integration

through a Platform as a

Service (Paas) model acts

as the “brain and nervous

system”, where the real

strategic thinking happens

inside the cloud. These are the

tools, capabilities and services

that solve complex business

problems.


In the middle layer of the cloud is Platform as a Service (PaaS). Although less familiar to most

companies, PaaS is critical to any successful interaction with the cloud. Components of PaaS

help take client data and transform it into useful and usable information.

At the outermost layer of the cloud lies Software as a Service (SaaS), which hosts applications

such as dashboards and charting programs created to help users consume information. Familiar

uses for SaaS applications include human resource packages, sales automation software and stock

option applications.

If you think of the cloud as a human body, SaaS would comprise the outward appearance—the skin.

These are the applications you see. IaaS in this analogy would consist of the skeleton; it is the structure

that holds everything up.

In the middle, the all-important PaaS would act as the brain and nervous system. This is where the real

strategic thinking happens inside the cloud. These are the tools, capabilities and services that can solve

complex business problems. PaaS includes services such as Integration as a Service, Data as a Service

and Information as a Service.

designing A PlAtform thAt creAtes ActionABle informAtionIntegration as a Service is an integration specialty that involves the ability to perform complex data

integration in the cloud. This technology operates in the background of a company’s IT systems,

allowing organizations to achieve greater functionality and scalability. It is a cost-effective solution

that allows large amounts of data to be transported and analyzed quickly, easily and intelligently

with fewer dedicated internal resources required than with traditional methods.

While the cloud itself provides a flexible and scalable environment for Integration as a Service, it is the

design of the platform that is crucial for answering the pharmaceutical and biotech industries’ data

integration challenges. To make information truly actionable and dynamic, a series of steps must take

place to connect, integrate, aggregate, harmonize and monetize the data:.

the Answer to dAtA integrAtion chAllenges

• Connectingdata consists of the ability to join disparate information technologies to send

information back and forth. The different methods to exchange information include FTP, HTTP,

SSH and others, but common protocols can enable connectivity among them. In the past, this

connectivity required large expenditures for hardware, software and other infrastructure. Today’s

cloud-based technology allows for much more efficient and cost-effective methods.

• Integratingdata is a function closely tied to connectivity. Instead of linking the physical IT

“plumbing”, integration links the data to make sure that different interfaces, information and

formats will work together seamlessly. This is a difficulty in traditional “point-to-point” integration

and is a significant advantage to taking a cloud-based approach.


Cloud-based integration can turn vast amounts of data from clinical trials, the manufacturing

process, point of service and point of sale into information that supports business decisions quickly

and accurately. Outsourcing through the cloud means that scalability, streamlined data mapping,

improved data quality and fast, flexible data management all can be obtained through one solution.

In addition, when implemented correctly by an experienced IT partner, set-up and management

should be a simple, seamless experience that requires limited investment in infrastructure.

ensuring dAtA security in the cloudEven in the face of all these unique advantages, one question remains in the minds of many industry

experts with regard to cloud-based data management—security. That is understandable; when it

comes to safeguarding clinical data, there is no margin for error. Cloud-based solutions can ensure

data privacy and security as readily as other approaches by focusing on access control, security of

stored data and security of data in transit. Access control involves guaranteeing that only the right

users have access to specific data. To ensure that appropriate levels of control are granted,

pharmaceutical and biotech companies should work with their vendors to develop service level

agreements that govern specific access requirements up front. These agreements hold the vendor

accountable and ensure more effective control. In addition, companies should choose a partner

with experience serving the health and/or financial industries to ensure that they have experience

in safeguarding highly sensitive information.

Other industries—such

as banking—have taken

advantage of cloud-based

technologies for years.

There is no need for the

pharmaceutical and biotech

companies to reinvent the

wheel. Instead, they should

consider reproducing those

“best practices”.

• Aggregatingdata involves assembling it from various sources to support large volumes of

information as well as enabling real-time access. Data aggregation, along with harmonization,

provides the ability for analytics to identify operational trends quickly and easily.

• Harmonizingdata is the most important step in the process of creating intelligent data.

It involves transforming data into a common, usable format, “normalizing” it to minimize

redundancy and dependency and then “translating” it to equitable semantic definitions.

For example, proper translation knows that field names such as surname and last name are

the same—and it eliminates duplication. True harmonization is achieved when the similarities

and differences in data sets are reconciled and actionable data emerges from considerable

volumes of diverse information.

• Monetizingdata is the process of using intelligent data to drive business activity. Translating

complex data for productive use and transforming it into meaningful insight allows companies to

monetize data by getting drugs and devices to market faster. By removing the burden of integration

and data management from internal IT staff, those resources then are free to work on activities

more directly related to market differentiation


cASe STudy: LIAISON HeALTHcAre HeLPS merck & cO., SOLve ISSueS wITH dATA FLOw IN megA TrIALS, eNAbLINg THe LeAdINg PHArmAceuTIcAL mANuFAcTurer TO AcHIeve greATer eFFIcIeNcy wITHIN THe cLINIcAL TrIAL PrOceSS

Liaison Healthcare consistently engages with many of the largest pharmaceutical manufacturers to

assist in increasing efficiency through data flow within the clinical trial process. Following is one case

study that illustrates the advantages of the company’s solution.

business issue

Merck’s internal IT systems have typically been able to accommodate standard, small clinical data trials.

However, a mega trial brought new challenges that the company’s legacy processes and tools- including

its datam-mapping tool - couldn’t support. While even standard trials needed efficiency improvements

in data flow processes, the sheer magnitude of the mega trial caused inconsistent data flow for analysis

purposes. The mega trial utilized more than 50% of all clinical data being collected that year and the

data flow problems caused delays in the start and completion of other clincial trials. This resulted in a

drain on overall corporate performance.

Merck was using a single map for all data that had to be deposited in the clinical data repository.

Because of the scope of the mega trial, the map size was extraordinarily large. Merck was required

to change the map every time there was a change in the study, regardless of how large or significant

the change was. Frequent changes meant there were ongoing changes in the map, which prevented

movement of data.

Merck’s Objectives

In enlisting the help of Liaison Technologies, Merck established clear and specific project objectives:

• reduce time – Reduce the number of days required to flow clinical trial data used for analysis

• Streamline the data mapping process – Implement a solution to streamline the mapping of key clinical trial data to standard formats

• reduce costs – Reduce costs by accelerating and streamlining processes and by efficiently using offshore resources

• enhance data quality – Implement a solution that would improve data integrity, reliability and completeness of the clinical data repository, the target system

• Achieve scalability – Redesign the data flow process and technical mapping components making them scalable and high performing

• Position for cloud-based implementation– Implement a solution that would not restrict

them from taking advantage of cloud-based services in the future.


Cloud-based integration can turn vast amounts of data from clinical trials, the manufacturing

process, point of service and point of sale into information that supports business decisions

quickly and accurately. Outsourcing through the cloud means that scalability, streamlined

data mapping, improved data quality and fast, flexible data management all can be

obtained through on solution.

the liaisOn healthcare sOlutiOn

Liaison analyzed the data flow problems and developed a solution based on Liaison’s mapping

platform. The recommended solution included:

• New processes- Design new map development, testing, and deployment processes to streamline and optimize map-development processes.

• more scalability- Design a hosted, scalable, run-time system capable of scaling to more than 200 clinical trials simultaneously

• Library of standard form-based data maps- Created a library of standard form-based maps that could be used repeatedly, from one trial to another, which enabled data flow in a more efficient and consistent manner

• Training-Train Merck and their offshore contract research organization (CRO), Accenture,

in how to use the new Contivo VMS solution.

the results: iMprOved efficiency, flexibility, siMplicity and scalability

Based on the success of a six-month pilot of Liaison’s solution, Merck decided to implement the solution

for interface mapping for all future clinical trials. Since then, Merck has begun to see improvements in the

data flow segments of its clinical trial process and is working with Liaison to gain the following business

efficiencies as a result of their efforts:

• Accelerated data flow processes –Using Liaison’s mapping solution, Merck now has the capability to create maps more efficiently, reducing the average map development process time. Another byproduct of this is that offshore resources are utilized more efficiently through the use of the standardized Liaison solution

• greater ability to change – Merck now has the ability to more easily change maps, making the data flow process more efficient

• Improved problem resolution – Merck replaced what was a sequential error identification and resolution process with a more dynamic process. Initial indications are that the overall reduction in trending errors is on track to meet their business objectives.

• greater capacity to handle multiple trials – Because Merck vastly improved its data

flow capabilities, it is now able to simultaneously conduct trials of more drugs, which is expected to increase its new drug pipeline

• more easily assimilate new business – As Merck acquires new companies, it is better

equipped to support clinical trial growth and volume

As the pharmaceutical and

biotech industries continue to

face new trends and challenges

that hasten the tempo of

business, innovation has

become the most important

precursor to profitability.

It is only through rapid

integration and interpretation

of intelligent data that business

decisions can keep up with this

accelerated process.


For more information contact:

3157 Royal DriveSuite 200Alpharetta, Georgia 30022Tel: 1.877.336.5163 or 1.770.442.4900Fax: 1.770.642.5050

keePing PhArmAceuticAl And Biotech comPAnies At the forefront of innovAtion

As the pharmaceutical and biotech industries continue to face new trends and challenges that hasten

the tempo of business, innovation has become the most important precursor to profitability. It is only

through the rapid integration and interpretation of intelligent data that business decisions can keep up

with this accelerated pace.

The vast amount of complex clinical data produced during product launches makes the life sciences

industry ideal for early adoption of cloud-based technology. Companies that do so will find success

and ease of implementation depend heavily on the proven expertise of their technology partners.

Experienced global companies like Liaison Healthcare will continue to be at the forefront, delivering

scalable, flexible data integration and harmonization solutions that can help their clients speed time

to market and capitalize on the best commercial opportunities.

ABout liAisonLiaison Technologies is a global integration, data harmonization and data management company,

serving more than 600 customers in the healthcare industry. With customized solutions offered via a

cloud-based platform, Liaison helps health systems, HIEs, pharmaceutical and bio-tech companies

quickly secure meaningful use from a wide variety of health information. For more information, visit

www.liaisonhealthcare.com.

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